RHINARIS-CS ANTI-ALLERGIC NASAL MIST SPRAY, METERED DOSE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CROMOLYN SODIUM

Disponibil de la:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

Codul ATC:

R01AC01

INN (nume internaţional):

CROMOGLICIC ACID

Dozare:

2%

Forma farmaceutică:

SPRAY, METERED DOSE

Compoziție:

CROMOLYN SODIUM 2%

Calea de administrare:

NASAL

Unități în pachet:

13ML/26ML

Tip de prescriptie medicala:

OTC

Zonă Terapeutică:

MAST-CELL STABILIZERS

Rezumat produs:

Active ingredient group (AIG) number: 0108810004; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2001-11-02

Caracteristicilor produsului

PRODUCT MONOGRAPH
RHINARIS-CS ANTI-ALLERGIC NASAL MIST
Cromolyn Sodium Nasal Solution USP
2%
W
/
V
Nasal Metered-Dose Mist
PREVENTION OF SEASONAL ALLERGIC RHINITIS
PENDOPHARM, DIVISION OF PHARMASCIENCE INC.
6111 Royalmount Avenue, suite #100
Montréal, QC, Canada
H4P 2T4
Date of Revision:
April 24, 2013
Control # 163420
2
PRODUCT MONOGRAPH
RHINARIS-CS ANTI-ALLERGIC NASAL MIST
Cromolyn Sodium Nasal Solution USP
2%
W
/
V
THERAPEUTIC CLASSIFICATION
Prevention of Seasonal Allergic Rhinitis
ACTION AND CLINICAL PHARMACOLOGY
In vitro and in vivo animal studies have shown that Cromolyn Sodium
(Sodium Cromoglycate)
inhibits the degranulation of sensitized mast cells occurring after
exposure to specific antigens.
Cromolyn Sodium acts by inhibiting the release of mediators from mast
cells. Studies show that
Cromolyn Sodium indirectly blocks calcium ions from entering the mast
cell, thereby preventing
mediator release.
Cromolyn Sodium has no intrinsic bronchodilator, antihistaminic or
anti-inflammatory activity.
It reduces the symptoms of seasonal rhinitis by blocking the release
of histamine and other
mediators of immunity rather than blocking H1-histamine receptors.
Cromolyn Sodium is poorly absorbed from the gastrointestinal tract but
is rapidly absorbed
following inhalation or intranasal administration. Once absorbed
Cromolyn Sodium is rapidly
cleared by the liver and kidneys prior to excretion in the bile and
urine. Apart from the liver and
kidneys there is no significant accumulation in any tissues.
Cromolyn Sodium is not metabolized and is excreted unchanged.
INDICATIONS AND CLINICAL USE
RHINARIS-CS ANTI-ALLERGIC NASAL MIST is indicated for the relief of
the nasal
symptoms of seasonal allergic rhinitis, such as congestion (stuffy
nose), sneezing and itchy,
runny nose.
CONTRAINDICATIONS
RHINARIS-CS ANTI-ALLERGIC NASAL MIST is contraindicated in those
patients who have
shown hypersensitivity to ingredients listed under COMPOSITION
section.
3
WARNINGS
1.
Patients should be instructed that if they do not obtain relief of